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藥物開發開發業務受託機關

市場調查報告書

商品編碼

1738669

2026 年至 2032 年醫藥契約製造和合約研究市場（按服務類型、最終用戶和地區分類）

Pharmaceutical Contract Manufacturing Contract Research Market By Service Type, End-User (Generic Pharmaceutical Companies, Large Pharmaceutical Companies, Small & Mid-Sized Pharmaceutical Companies), & Region for 2026-2032

出版日期: 2025年05月02日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

2026-2032 年醫藥契約製造與合約研究市場評估

將生產和研究業務委託給專業公司的製藥公司本質上採用的是契約製造和合約研究。合約研究組織 (CRO) 提供各種服務，例如臨床試驗管理、數據分析和監管諮詢；而受託製造廠商(CMO)監督藥品生產，確保其符合品質和監管標準。受這些因素影響，預計到 2024 年，市場規模將超過 1,765 億美元，到 2032 年將達到約 3,243 億美元。

疾病研究數量的不斷成長刺激了對學名藥的需求，從而鼓勵生物製藥行業拓展藥品契約製造和合約研究市場。此外，臨床試驗的全球化、對更廣泛和多樣化測試的需求以及嚴格的監管標準，使得外包成為尋求降低風險和控制成本的製藥公司的一個有吸引力的選擇。藥品契約製造和合約研究需求的不斷成長，推動該市場在2026年至2032年間以7.9%的複合年成長率成長。

醫藥契約製造與研究市場：定義/概述

契約製造和合約研究涉及委託給專業公司。藥品製造由受託製造廠商(CMO) 負責，該組織還確保藥品符合品質和監管標準。委外研發機構(CRO) 提供數據分析和臨床試驗管理等服務，使製藥公司能夠專注於其核心競爭力，同時降低成本並加快藥物開發速度。

合約研究涉及委託一系列研究活動，包括數據分析、監管諮詢和臨床試驗管理。契約製造涉及將藥品生產委託給專業機構，以確保品質和合規性。這些服務有助於製藥公司滿足日益複雜和國際化的市場需求，降低成本，加快藥物開發速度，並專注於核心競爭力。

其未來取決於受託製造和研發在加速藥物研發、提高生產效率和確保合規性方面發揮的重要作用。在日益複雜且競爭激烈的製藥行業中，這些服務可幫助製藥公司利用外部知識、獲得專業設施並最佳化流程——所有這些最終都有助於加快產品進入市場、最佳化成本並改善患者治療效果。

醫藥全球化將如何推動醫藥受託製造市場？

全球化是推動醫藥受託製造需求成長的主要因素之一。醫藥市場不斷超越傳統邊界，為尋求在不同國家開展業務的公司創造了機會。這一趨勢在開發中國家醫療成本的上漲、人口的成長以及法規環境的改善，使它們成為對製藥公司更具吸引力的投資目的地。

在製藥業，全球化催生了複雜的供應鏈。此外，由於成品、中間體和原料的採購來自世界各地，因此對高效生產和分銷的需求也日益成長。為了解決這個問題，製藥契約製造使企業能夠利用位於關鍵地區的策略性製造地網路。因此，那些需要縮短前置作業時間、簡化供應鏈並快速響應消費者需求變化的營運商在市場上佔據了有利地位。

製藥業正朝著全球化發展，這鼓勵知識共用和資源的有效利用，因此製藥企業和製造外包的合作日益增加。為了適應全球市場情勢，製藥公司可以與全球製造外包合作，在國際市場上進行談判，縮短產品上市時間，並確保更有效率、更具成本效益的方法。

不同的地區監管要求是否會阻礙醫藥受託製造市場的發展？

在製藥業，忽視監管要求會對公司及其品牌造成不利影響已是眾所周知的事實。因此，遵守法規至關重要，因為違規可能會造成嚴重後果。製藥公司利用受託製造廠商(CDMO) 來開發藥物成分和製劑，而 CDMO 是這項流程中不可或缺的一部分。由於這些藥品通常以合約公司的品牌銷售，因此在整個生產過程中保持高品質標準至關重要，從而影響市場成長。

預計未來幾年，監管合規的困難將阻礙醫藥CDMO市場的擴張。為了有效管理監管數據和提交，CDMO需要投資強大的系統和流程。這需要改進培訓計劃，以確保員工掌握最新的最佳實踐和監管義務，並採用現代技術解決方案進行資料管理和監管報告。

法規合規性在製藥業至關重要，尤其對於合約受託製造廠商(CDO) 而言。如果不同學科的監管數據和提交處理不一致，監管文件很容易出錯。投資尖端技術解決方案、改進培訓以及與行業相關人員和監管機構密切合作可能充滿挑戰。儘管面臨這些挑戰，但積極採取措施確保法規合規性有助於降低風險，並促進製藥 CDMO 的長期發展和繁榮。

Lonza Group（Switzerland）
Catalent, Inc.（US）
Thermo Fisher Scientific（US）（acquired Patheon）
Recipharm AB（Sweden）
Boehringer Ingelheim（Germany）
WuXi AppTec（China）
Samsung Biologics（South Korea）
Dr. Reddy's Laboratories（India）
Jubilant Life Sciences（India）
Almac Group（Northern Ireland）

第11章市場展望與機會

新興技術
未來市場趨勢
投資機會

第12章附錄

簡稱列表
來源和參考文獻

簡介目錄

Product Code: 35786

Pharmaceutical Contract Manufacturing Contract Research Market Valuation - 2026-2032

Pharmaceutical enterprises that outsource their manufacturing and research operations to specialist companies are basically using the pharmaceutical contract manufacturing and contract research. While Contract Research Organizations (CROs) offer a variety of services like clinical trial administration, data analysis, and regulatory consultation, Contract Manufacturing Organizations (CMOs) supervise the production of medications and make sure they fulfil quality standards and regulatory criteria. These factors are likely to enable the market size surpass USD 176.5 Billion valued in 2024 to reach a valuation of around USD 324.3 Billion by 2032.

Rising incidences of diseases is surging demand for generic drugs, thereby encouraging enabling biopharmaceutical industry explore the pharmaceutical contract manufacturing and contract research market. Additionally, the globalization of clinical trials, the need for more extensive and varied testing, and stringent regulatory standards have made outsourcing an attractive option for pharmaceutical companies looking to mitigate risks and manage expenses. The rising demand for pharmaceutical contract manufacturing contract research is enabling the market grow at a CAGR of 7.9% from 2026 to 2032.

Pharmaceutical Contract Manufacturing Contract Research Market: Definition/ Overview

Pharmaceutical contract manufacturing and contract research entail contracting out the creation of pharmaceuticals and research to specialized companies. Drug manufacture is handled by Contract manufacture Organizations (CMOs), who also make sure that quality and regulatory standards are met. By offering services like data analysis and clinical trial management, contract research organizations (CROs) free up pharmaceutical corporations to concentrate on their core competencies while reducing expenses and expediting medication development.

Contract research include contracting out a range of research activities, including data analysis, regulatory advice, and clinical trial management. Pharmaceutical contract manufacturing involves contracting out the production of medications to specialist organizations, guaranteeing quality and compliance with regulations. These services help pharmaceutical businesses in meeting the needs of a more complicated and international market, reducing expenses, speeding up drug development, and concentrating on their core capabilities.

The key role that pharmaceutical contract manufacturing and research will play in expediting drug discovery, improving production efficiencies, and ensuring regulatory compliance will determine their future. In an increasingly complicated and competitive pharmaceutical industry, these services help pharmaceutical companies to take use of outside knowledge, gain access to specialized facilities, and optimize processes, all of which eventually contribute to more rapid market entrance, cost optimization, and improved patient outcomes.

How will the Globalization of the Pharmaceutical Industry Drive the Pharmaceutical Contract Manufacturing Contract Research Market?

Globalization is one of the main factors contributing to the rise in demand for pharmaceutical contract manufacturing. Growth of pharmaceutical markets outside of conventional borders are creating opportunities for businesses trying to develop a presence in a variety of countries. This tendency has been especially noticeable in developing nations, where expanding healthcare costs, expanding populations, and bettering regulatory environments are making it more attractive for pharmaceutical companies to invest.

In the pharmaceutical sector, complicated supply chains are emerging as a result of globalization. Also, the necessity for effective manufacturing and distribution procedures is growing as businesses acquire their finished pharmaceuticals, intermediate goods, and raw materials from many parts of the world. To address this issue, pharmaceutical contract manufacturing gives businesses access to a network of strategically placed manufacturing sites in important areas. Thus, the need shorten lead times, streamline their supply chains, and react quickly to shifts in consumer demand by the business is a boon to the market.

Pharmaceutical businesses and contract manufacturers collaborate more often as a result of the industry's tendency toward globalization, facilitating the sharing of knowledge and effective use of resources. Pharmaceutical businesses may negotiate international markets, shorten time-to-market, and assure a more efficient and cost-effective way to meet the increasing demands of a globalized pharmaceutical landscape by collaborating with contract manufacturers globally.

Will the Varying Regulatory Requirements Across Regions Hamper the Pharmaceutical Contract Manufacturing Contract Research Market?

In the pharmaceutical industry, neglecting regulatory requirements is known to have negative impacts on companies and their brands. Thus, compliance with regulations is essential since noncompliance can have severe consequences. Pharmaceutical businesses rely on Contract Development and Manufacturing Organizations (CDMOs) to develop medicinal ingredients and formulations, and CDMOs are essential to this process. Since the contractor's brand is frequently used to sell these medications, it is crucial to maintain high standards of quality throughout the manufacturing process, impacting the growth of the market.

In the upcoming years, it is expected that the difficulties related to regulatory compliance will impede the pharmaceutical CDMO market's expansion. To efficiently manage regulatory data and submissions, CDMOs will need to invest in strong systems and processes as the business grows more worldwide and regulatory requirements become more intricate. Thereby, entailing in improving training programs to guarantee that employees are knowledgeable about best practices and regulatory obligations, as well as putting modern technological solutions for data management and regulatory reporting into place.

In the pharmaceutical sector, regulatory compliance is critical, especially for contract drug manufacturing organizations (CDOs). Errors in regulatory files are more likely when regulatory data and submissions are handled inconsistently across different areas. Investments in cutting-edge technological solutions, improved training initiatives, and tighter coordination with industry players and regulatory bodies are proving difficult. Despite these difficulties, proactive steps taken to guarantee regulatory compliance can reduce risks and promote the long-term development and prosperity of pharmaceutical CDMOs.

Category-Wise Acumens

Will Increase in Drug Development Process Drive the Contract Manufacturing Organization Segment?

Rising focus on drug discovery by the pharmaceutical manufacturers is expected to propel the Contract Manufacturing Organization (CMO) segment's expansion. This tendency is influenced by a number of reasons, such as the growing need for novel treatments, the growth of biopharmaceuticals, and the difficulty of contemporary drug development.

The need for new therapies to fill unmet medical needs is surging, according to the pharmaceutical industry. Globally, the incidence of chronic illnesses is increasing, making it more and more necessary to create innovative therapies that provide better patient outcomes, safety, and efficacy. Pharmaceutical companies have been investing extensively in research and development (R&D) as a result of this increased focus on innovation, which has increased the number of medication candidates entering the development pipeline.

The need for production flexibility and scalability offered by CMOs among the pharma firms with strategically placed facilities in key global locations. This allows the companies to tap into local markets and react promptly to fluctuations in demand. The pharmaceutical firms are streamlining their supply chains, reducing logistical obstacles, and guarantying regulatory compliance across many countries by working with global CMOs.

Increasing focus of pharmaceutical industries on drug discovery is creating growth opportunities for the Contract Manufacturing Organization (CMO) segment. Thus, pharmaceutical companies are becoming more dependent on outside partners for manufacturing support due to factors like the growing need for novel therapies, the growth of biopharmaceuticals, the complexity of drug development, and the globalization of the pharmaceutical industry.

Will Rise in Adoption of Clinical Trial Development Drive the Pharmaceutical Contract Manufacturing and Contract Research Market?

The pharmaceutical contract manufacturing and contract research market is anticipated to be driven by the high emergence of clinical trial development. In addition to this, pharmaceutical companies are expanding their investments in clinical research to bring novel pharmaceuticals to market, in response to the growing need for novel treatments and therapies. The need for specialized services provided by Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), such as trial design, patient recruiting, data management, and the production of investigational pharmaceuticals, is fueled by the increase in clinical trial activities. In order to support the growing clinical trial landscape, the market for pharmaceutical contract manufacturing and contract research is growing significantly.

Trial design entails carefully organizing the procedure of the trial, including participant eligibility requirements, treatment schedules, and outcome evaluations. Finding and recruiting eligible individuals while abiding by ethical standards is the task of patient recruitment. Accurate and secure trial data collection, archiving, and analysis are guaranteed via data management.

Pharmaceutical companies are turning to CROs for specialized expertise due to the growing complexity of clinical trial protocols. Clinical trials nowadays are getting more complicated, combining new technologies, creative research designs, and sophisticated data analytics methods. Adaptive trial designs, for example, provide real-time protocol modifications by researchers in response to interim data analysis, thereby optimizing patient recruitment, treatment allocation, and trial efficiency.

Country/Region-wise Acumens

Will the increasing Research Funding for drug development drive the North America region?

North America boasts high concentration of pharmaceutical companies especially in areas like the US and Canada. These businesses, which range in size from big multinational conglomerates to smaller biotech startups, all support a healthy pharmaceutical environment. Large pharmaceutical businesses provide an ideal environment for contracting out research and manufacture to specialized CMOs and CROs. These businesses support the drug development process by utilizing their infrastructure, experience, and regulatory compliance, which propels the expansion of the CMO/CRO industry in the area.

The CMO segment's growth is being driven by the rising demand for generic medications in North America. Because they are more affordable than name-brand drugs, generics are becoming more and more appealing to payers, healthcare providers, and patients. As a result, in order to fulfil market demand, pharmaceutical companies are increasing the production of generic medications, which is increasing the demand for contract manufacturing services. CMOs are essential to the creation of generic medications because they provide scalable and effective production solutions that help pharmaceutical companies launch generic goods into the market at a reasonable price.

The prevalence of numerous pharmaceutical companies, the rising demand for generics, and increased funding for research and development for contract manufacturing and development are some of the factors contributing to North America's market dominance in pharmaceutical contract manufacturing and contract research

Will Increase in Demand of Generic Drugs Drive the Asia Pacific Region?

The Asia-Pacific region Driven by a number of critical variables that position the region for quick expansion and importance in the industry, the Asia-Pacific area is emerging as a major player in the pharmaceutical contract manufacturing market. Pharmaceutical businesses looking to minimize production costs while upholding quality standards find Asia-Pacific's cost-effective manufacturing capabilities to be very appealing. The area gains from reduced labor expenses, advantageous tax laws, and infrastructure improvements that facilitate effective and simplified production procedures.

The Asia-Pacific pharmaceutical contract manufacturing industry is expanding due to rising demand for biopharmaceuticals and generic medications. Worldwide demand for generic drugs is significant because they provide affordable substitutes for branded pharmaceuticals, especially in developing nations where access to affordable healthcare is a top concern.

In light of its cost-effective manufacturing capabilities, trained workforce, regulatory compliance, and important positioning in the global pharmaceutical supply chain, Asia-Pacific is expected to experience substantial expansion in the pharmaceutical contract manufacturing market. It is anticipated that the region's reputation as a center for contract manufacturing services will only get stronger as pharmaceutical companies looking for scalable and effective production solutions continue to draw to the area, driving more expansion and innovation in the sector.

Competitive Landscape

The pharmaceutical contract manufacturing contract research market is a dynamic and competitive space, characterized by a diverse range of players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations are focusing on innovating their product line to serve the vast population in diverse regions.

Some of the prominent players operating in the pharmaceutical contract manufacturing contract research market include:

Lonza Group
Catalent, Inc.
Thermo Fisher Scientific (acquired Patheon)
Recipharm AB
Boehringer Ingelheim
WuXi AppTec
Samsung Biologics
Reddy's Laboratories
Jubilant Life Sciences
Almac Group
Patheon (Now part of Thermo Fisher Scientific)
Fareva
Vetter Pharma
Evonik Industries
Pfizer Centre One
AbbVie Contract Manufacturing

Latest Developments

In February 2022 Lonza Group and Touch light, a biotechnology startup, partnered to improve Lonza Group's full mRNA synthesis capabilities by adding another supply of DNA.
In February 2022, Moderna, Inc. and Thermo Fisher Scientific partnered in February 2022 to enable Moderna's COVID-19 vaccine, Spikevax, and other experimental mRNA medicines under development to be produced on a large scale.
In January 2023, Catalent was instrumental in facilitating the production process of delandistrogene moxeparvovec (SRP-9001), an advanced gene therapy candidate developed by Sarepta to treat Duchenne muscular dystrophy.